Living Donor of Kidney
Conditions
Keywords
4D computed tomography, Kidney function tests, Living Donors
Brief summary
The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).
Interventions
OTHERDifferential renal function assessment by 4D CT
Low dose 4D (perfusion) renal acquisition after injection of iodinated contrast medium (ICM) (13 passes every 3 seconds, 3 passes every 10 seconds); estimated additional DLP 400 mGy.cm No additional contrast medium
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment * Mandatory enrollment in a health security plan (French Social Security) * Subject having signed an informed consent
Exclusion criteria
* Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy * Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney) * Subjets under a legal protection measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| degree of agreement | through study completion (2 years) | Differential renal function (DRF) measured by each technique (CT and SPECT) Regions of interest will be drawn on each kidney and the aorta to obtain time-intensity curves and derive the Patlak plot; the Patlak model will then be used to determine the slope of each kidney and thus to calculate the differential renal function (percentage of each kidney in the total renal function). Degree of agreement will be assessed by calculating the intra-class correlation coefficient and its 95% confidence interval, and the Bland-Altman plot. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra- and inter-observer reproducibility of CT DRF measurement | through study completion (2 years) | — |
| Radiation dose exposure for each technique | 1 day | Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up |
| Agreement between post-processing methods for CT | through study completion (2 years) | Comparison between Patlak-Ruthland method, its modified version and the area under the curve method |
| Automatic post-processing for Patlak-Ruthland method | through study completion (2 years) | — |
Countries
France
Outcome results
None listed